TMF Study Owner

Parexel FSP is seeking a
TMF Study Owner
to join our team in Argentina

Job Overview
Trial Master File (TMF) Study Owner (SO)
is:

• Subject Matter Expert to and single point of contact for the Project Manager (PM) or equivalent and study team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.
• Accountable to the PM or equivalent for all global Trial Master File responsibilities conducted internally as well as externally at preferred providers and Contract Research Organizations (CROs).
• To provide crucial TMF quality support to the study team and to establish a proactive quality-focused partner relationship with the study team.

Job Responsibilities

• Contributes to the development and assists with the implementation of the TMF specifications, such as process and system changes.
• Leads the set-up of the TMF Study Specific Document List (SSD...